CLINICAL STUDIES WITH MEDICINAL PRODUCTS

These are experimental studies that are carried out in humans and involve the use of an unauthorised drug as a medicinal product, or different use conditions than those authorised. They are governed by the provisions laid down in Royal Decree 1095/2009, and may have some of the following characteristics:
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-  The assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within routine clinical practice.
-  The decision to prescribe investigational medicinal products is taken together with the decision to include the subject in the clinical study.  
-  Diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
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Find below the assessment requirement files depending on the procedure to be completed:
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 ASSESSMENT REQUIREMENTS FOR INITIAL APPLICATIONS
 SUBMISSION REQUIREMENTS FOR CLARIFICATION RESPONSES
 ASSESSMENT REQUIREMENTS FOR RELEVANT AMENDMENTS

CLINICAL RESEARCH WITH MEDICINAL DEVICES
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This is a study carried out in humans that aims to verify the safety and/or benefits of a medical device.     
A medical device is any article to be used for humans for diagnosis, prevention, control, treatment or alleviation of disease, injury, deficiency or control of conception which does not achieve its primary action by pharmacological, immunological or metabolic means.
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Clinical trials with medical devices shall be considered as such when patients are randomly assigned to an intervention group or when the medical device is used for different indications or under different conditions of use from those listed in the summary of product characteristics. They shall be regulated under Royal Decree 1095/2015.
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Find below the assessment requirement files depending on the procedure to be completed:
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 ASSESSMENT REQUIREMENTS FOR INITIAL APPLICATIONS
 SUBMISSION REQUIREMENTS FOR CLARIFICATION RESPONSES
 ASSESSMENT REQUIREMENTS FOR RELEVANT AMENDMENTS

RESEARCH PROJECTS
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Any basic, clinical or translational research study involving humans, human samples or personal data shall be considered a biomedical research project. They shall be regulated under law 14/2007 on biomedical research. Clinical trials and post-authorisation observational studies would be excluded, since they are regulated under specific legislation.

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Find below the assessment requirement files depending on the procedure to be completed:
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 ASSESSMENT REQUIREMENTS FOR INITIAL APPLICATIONS
 SUBMISSION REQUIREMENTS FOR CLARIFICATION RESPONSES
 ASSESSMENT REQUIREMENTS FOR RELEVANT AMENDMENTS

OBSERVATIONAL STUDY WITH MEDICINAL PRODUCTS

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Any investigation that requires the collection of individual data related to people’s health, provided that it does not meet any of the conditions required to be considered a clinical trial (see Royal Decree 1090/2015), and that it is carried out with any of the following purposes:

- Determining the beneficial effects of medicinal products, as well as their modifying factors, including the patients’ perspective.
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- Identifying or quantifying the adverse reactions of medicinal products and other risks for the patients’ safety related to their use, including possible risk factors or effect modifiers, as well as measuring the effectivity of risk management measures.
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- Obtaining information on the patterns of the use of medicinal products in the population.
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Find below the assessment requirement files depending on the procedure to be completed:
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 ASSESSMENT REQUIREMENTS FOR INITIAL APPLICATIONS
 SUBMISSION REQUIREMENTS FOR CLARIFICATION RESPONSES
 ASSESSMENT REQUIREMENTS FOR RELEVANT AMENDMENTS